Drug Eluting Balloon for Treatment of Unstable Angina

Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02760732

Enrollment

Registered

2016-05-04

Start date

2015-11-30

Completion date

2018-08-01

Last updated

2017-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina, Unstable

Brief summary

This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.

Detailed description

Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .

Interventions

DEVICEdrug eluting balloon; cutting balloon

Patients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon.

DEVICEdrug eluting stent

with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients \> 18, \< 80 years old, with unstable angina * Single-vessel or double-vessel disease * Length of target lesion \< 25mm * Diameter of target vessel \>2.5mm, \< 3.5mm

Exclusion criteria

* Left main disease * Chronic total occlusion * Severe Tortuosity * Heavy calcification * Severe liver failure, moderate or severe kidney failure * Malignant disease * Active infectious disease * Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame	Description
Changes in Target Lumen assessed by optical coherence tomography	12 months	A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months.

Secondary

Measure	Time frame	Description
Incidence rate of MACE	Incidence rate of MACE from baseline to 12 months	MACE include composite of death, myocardial infarction, or target-vessel revascularization

Countries

China

Contacts

Primary ContactLI BO, MD

22401919@qq.com+8601055499309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026